Establishing genetic and immunologic profiles for advanced cancer patients
Program to Establish the Genetic and Immunologic Profile of Patient's Tumor for All Types of Advanced Cancer
This study is trying to create personalized treatment plans for people with advanced cancer by looking at the genetic and immune features of their tumors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10000 (estimated) |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Locations | 6 sites (Annecy and 5 other locations) |
| Trial ID | NCT01774409 on ClinicalTrials.gov |
What this trial studies
This program aims to implement a personalized cancer medicine approach by establishing the genetic and immunologic profiles of tumors in patients with advanced malignant tumors. It involves a non-randomized, multicentric cohort study that collects biological samples and clinical data to analyze genetic mutations and immunologic markers. The findings will be reviewed by a multidisciplinary molecular board to adapt therapeutic management, potentially offering targeted therapies or immunotherapies based on the profiles identified. The study does not evaluate treatment efficacy but focuses on profiling to guide future treatment options.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically or cytologically confirmed advanced malignant tumors who have accessible tumor samples for genetic profiling.
Not a fit: Patients with early-stage cancers or those without accessible tumor samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with advanced cancers.
How similar studies have performed: Other studies have shown success in using genetic and immunologic profiling to guide cancer treatment, indicating that this approach is promising and not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced (locally-advanced or metastatic) malignant tumor of any histological type * Tumor sample available to determine the genetic profile: either archival tumor sample \[FFPE (formalin fixed and paraffin embedded)\] or perform a new biopsy on an accessible lesion (left at the investigator's appreciation). For biopsies, presence of at least one tumor lesion with a diameter ≥ 20 mm, visible by medical imaging and accessible to repeatable percutaneous (needle biopsies 18 gauge or larger) sampling that permit core needle biopsy (ideally 4 cores) without unacceptable risk of a major procedural complication. Please note that brain and bone lesions are not considered as accessible lesions. * Patient with 1st, 2nd or 3rd line therapy (NB: endocrine therapy (monotherapy) are not considered as line therapy) for advanced / metastatic cancer. * For patients over 70 years of age, a Performance Status (PS) of 0 on the ECOG scale. * Patient must be covered by a medical insurance. * Informed consent signed by the patient and/or by parents (or legal representative) for patients below 18. Exclusion Criteria: * No tumor sample available.
Where this trial is running
Annecy and 5 other locations
- Centre Hospitalier Annecy Genevois — Annecy, France (Recruiting)
- Groupement Hospitalier Mutualiste — Grenoble, France (Recruiting)
- Hôpital Edouard Herriot — Lyon, France (Not_yet_recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Centre Hospitalier Lyon Sud — Pierre-Bénite, France (Active_not_recruiting)
- CHU de Saint-Etienne Hôpital Nord — Saint-Etienne, France (Recruiting)
Study contacts
- Principal investigator: Jean-Yves BLAY, MD PhD — Centre Leon Berard
- Study coordinator: Jean-Yves BLAY, MD
- Email: jean-yves.blay@lyon.unicancer.fr
- Phone: +33 4 78 78 51 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.